When the FDA committee Consideration is being given to whether to recommend legal production of seven peptides meets from Thursday, Shaun Noorian will be on campus in person at Maryland. “I wouldn’t miss it for the world,” says Noorian, the founder and CEO of Houston-based Empower Pharmacy, one of the largest compounding pharmacies in the country Forbes. “The who’s who of the peptide industry will be there.”
Hundreds of others are also expected to flock to the room, including compounders, telemedicine founders and longevity influencers flying in for the event. “It’s going to be a circus,” says Scott Brunner, CEO of the Alliance for Pharmacy Compounding, the industry’s trade group. “Everyone and their brother is coming.”
While producing these peptides for purposes other than “research” isn’t currently legal, that hasn’t stopped a booming gray market from exploiting this loophole. There is little scientific data on their safety and effectiveness, and the many shady sellers who distribute them operate without oversight. Still, the illegal peptide market could be worth an estimated $3 billion. Silicon Valley bros, longevity doctors and MAHA believers are taking them, while wellness influencers are promoting their “peptide stacks” online to speed recovery or improve sleep. Health and Human Services Secretary Robert F. Kennedy Jr. is a self-proclaimed politician “big fan of peptides” as he told podcaster Joe Rogan in February.
While peptides represent a broad category of amino acid-based drugs that also include well-known legal medications (such as insulin and the GLP-1 weight-loss drugs), the buzz—and the FDA panel—is focused on a number of them, known by a series of letters and numbers. These are injectables such as BPC-157, which is extremely popular online for its purported ability to heal tendons, ligaments and muscles, and TB-500, which is believed to reduce inflammation and improve wound healing. “This is similar to the supplement industry,” says Michelle Davey, founder and CEO of telehealth company Wheel. “I have a feeling it’s going to be the Wild West for at least the first six months.”
“It’s going to be a circus. Everyone and their brother is coming.”
Kennedy argued that legalizing these substances would make them safer by blocking Americans from the existing gray market. There’s some truth to that. When people buy peptides directly from China or other countries, there is a risk of contamination, incorrect dosage or other problems – and buyers cannot easily tell whether they actually received the peptide they purchased. Legalization would also make these substances, whose effectiveness has not been proven, more readily available and given a seal of quality. That’s why the FDA’s technical staff has recommended against expanded access, and the health group Partnership for Safe Medicines calls it “popular, unproven, dangerous.” As Peter Kolchinsky, managing partner of biotech investor RA Capital Management, puts it: “Will the FDA rely on the science or will they allow all kinds of snake oil to be readily available?”
The FDA meeting will last two days. The panel is widely expected to recommend allowing compounders to produce at least some of the seven peptides being tested on what some online commentators have dubbed “Peptide Liberation Day.” An additional five peptides will be considered in 2027. The panel will pass on its recommendations to the FDA, which will then decide whether to proceed the process the approval of these peptides. This approval can last as little as a few months or as long as a year.
This brings a potential multibillion-dollar market within reach for pharmacies like Empower, telemedicine giant Hims & Hers and many others that can produce medications specifically for individual patients.
“We would like to make them and are preparing to do so,” says Mike Walker, co-founder and president of Strive Pharmacy, another major compounder. “We’re just waiting for the green light from the FDA.”
Covercrowded pharmacies are a step backwards in some respects. A century ago, three-quarters of prescriptions required some sort of pharmacy compounding—mixing drug formulations in the store rather than giving a patient a standard off-the-shelf medication—but that number was fell to 1% by the 1970s. Over the past two decades, compounding has been given new life with the boom of testosterone for men, hormone replacement therapies for women and, more recently, GLP-1 weight loss drugs. (Compounders must follow manufacturing regulations, but the drugs they produce are not FDA-approved.)
Noorian, a former mechanical engineer, founded Empower Pharmacy in 2009 after using a compounded medication to treat his own low testosterone levels at age 24. Today, the company has two 20,000-square-foot manufacturing facilities in Houston. (The expansion was not without problems: Empower was received several warning letters from the FDA about quality concerns. Empower says it takes every inspection seriously.)
Strive Pharmacy, founded in Utah in 2018 by Walker and his childhood friend Nate Hill, acquired a 25,000-square-foot manufacturing and outsourcing facility in Alachua, Florida, in November. In December, ground was broken on a new 350,000-square-foot headquarters and modern compounding facility in Mesa, Arizona, expected to open in early 2027.
“We would like to make them, and we are preparing to do so. We are just waiting for the green light from the FDA.”
Across the country, compounding pharmacies such as Houston-based ReviveRx and Fort Lauderdale-based Hallandale have emerged or expanded, while private equity-backed Revelation Pharma has consolidated compounding pharmacies into one larger operation. Hims & Hers, the telehealth giant with a market value of $7.6 billion, even acquired its own compounding pharmacy in September 2024.
These compounders have boomed in recent years, especially when GLP-1 weight loss drugs became so popular that they were thought to be in short supply. Compounding pharmacies could legally produce them to fill the gap. The shift to telemedicine also made compounded medications, which are generally cheaper, more readily available. But as GLP-1 shortages eased, a large portion of the compounder’s business was suddenly at risk. Some still continued to sell knockoffs of GLP-1, prompting regulators to crack down on false advertising and piracy. GLP-1 pharmaceutical giants Eli Lilly and Novo Nordisk have hit some of them with lawsuits.
For compounders who have avoided the GLP-1 space because of its legal risk, and for those whose business in this area is waning, peptides are the obvious answer. “For those players who have built their infrastructure on GLP-1s, this is the place to be,” says Wheel’s Davey. It is important that no pharmaceutical company owns patents on the peptides in question. “No one can say that these drugs should be manufactured by traditional pharmaceutical companies,” says Noorian.
It’s not just compounders that will come into play, says Davey. She believes non-traditional healthcare players and vitamin and supplement manufacturers will also look to take advantage of the opportunity.
Jon Lensing, CEO of OpenLoop, a VC-backed startup that runs telehealth operations for clients under its own brand, says his customers — including major gym chains — have been asking for peptides. “Patients want comfort,” he says. “Why wouldn’t a gym allow access?”
“No one can say that these drugs should be manufactured by traditional pharmaceutical companies.”
The land grab has also left investors looking for ways to get in. “We already have customers who are positioning themselves for this,” says Jesse Dresser, partner at Frier Levitt. “The compounders and telehealth companies – the targets, so to speak – are currently in discussions with private equity groups and VC firms.”
To prepare for the FDA decision, Noorian says Empower has been “preparing for months,” including research and development to ensure its formulations are stable and that the company can offer peptides as injections, pills and nasal sprays to meet expected demand. He expects Empower’s revenue from peptides could ultimately reach “several hundred million dollars.”
Hims & Hers is also currently building out its infrastructure and clinical protocols to prepare for the production and sale of peptides if approved. Industry observers expect the company to be one of the largest players in this space due to its size. Last month the company Dr. Anant Vinjamoori, a Harvard-trained longevity expert, was hired as Hims’ chief medical officer. One focus: the company’s strategy for peptide therapy.
Although the FDA committee makes a recommendation for peptides this week, it is unclear when the timing for final approval will be. Then it won’t be so easy to unlock the supply chains for them. Because these peptides are not currently legal for consumers, only research-grade pharmaceutical ingredients are currently available that are not approved in human drugs, explains Brunner of the Compounding Industry trade group. Building supply chains for pharmaceutical ingredients that meet complex manufacturing and quality regulations could take months — or perhaps longer if the government were to require them to come from the U.S. instead of China.
“Everyone can cheer and cheer and hope that the FDA approves these substances,” says Brunner. “The dilemma that many people don’t talk about is supply chain management.”
But the market is just too tempting. “Given the number of peptides we’re talking about, there’s the potential that the experience we’ve just had with GLP-1 seems small in comparison,” he says.
